Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06461039 | A Research Study Looking at How the Compound NNC0487-0111 Works With Birth Control Pills and Affects Emptying of the Stomach in Women Not Able to Become Pregnant | PHASE1 | COMPLETED | 43 | — | — | Jun 14, 2024 | Apr 4, 2025 | May 8, 2025 | 1 | Canada |
| NCT05369390 | A Research Study on How NNC0487-0111 Works in People With Overweight or Obesity | PHASE1 | COMPLETED | 144 | — | — | May 11, 2022 | Jan 9, 2024 | Jun 15, 2025 | 2 | United States |
Measured as hours picograms per milliliter (h\*pg/mL).
Measured as hours picograms per milliliter (h\*pg/mL).
Number of events
| Arm | Type | Description |
|---|---|---|
| NNC0487-0111 | EXPERIMENTAL | Participants will receive oral dosing of NNC0487-0111 and gradually will escalate from dose 1 to dose 2. The oral NNC0487-0111 treatment will be followed by s.c. NNC0487-0111 treatment with dose escalating from dose 3 to dose 4. |
| Part A: Single ascending dose (SAD) | EXPERIMENTAL | Participants will receive a single dose of any of the six different dose levels (1, 3, 6, 12, 25 and 50 milligrams (mg)) of NNC0487-0111 A or matching placebo in a sequential manner with the dose increasing between cohorts. |
| Part B: Multiple ascending dose (MAD) | EXPERIMENTAL | Participants will receive NNC0487-0111 once daily for 10 days at any of the five different dose levels (3, 6, 12, 25 and 50 milligrams (mg)) of NNC0487-0111 A or matching placebo in a sequential manner with the dose increasing between cohorts. |
| Part C | EXPERIMENTAL | Participants will receive NNC0487-0111 A or matching placebo once-daily for 12 weeks: 3 or 6 mg for weeks 1-2, 6 or 12 mg for weeks 3-4, 12 or 25 mg for weeks 5-6, 25 or 50 mg for weeks 7-8, 25 or 50 mg for weeks 9-10 and 50 or 2\*50 mg for weeks 11-12. |
| Part D | EXPERIMENTAL | Participants will receive NNC0487-0111 B or matching placebo once-daily for 12 weeks: 3 or 6 mg for weeks 1-2, 6 or 12 mg for weeks 3-4, 12 or 25 mg for weeks 5-6, 25 or 50 mg for weeks 7-8, 25 or 50 mg for weeks 9-10 and 50 or 2\*50 mg for weeks 11-12. |
| Name | Type | Description |
|---|---|---|
| NNC0487-0111 A | DRUG | NNC0487-0111 A will be administered subcutaneously. |
| NNC0487-0111 C | DRUG | NNC0487-0111 C will be taken orally. |
| Levonorgestrel 150 μg + Ethinylestradiol 30 μg (Oral contraceptive OC) | DRUG | Levonorgestrel 150 μg + Ethinylestradiol 30 μg (Oral contraceptive OC) will be taken orally. |
| Acetaminophen - 500 mg/15 ml | DRUG | Acetaminophen - 500 mg/15 ml will be taken orally. |
| NNC0487-0111 B | DRUG | Participants will receive NNC0487-0111 B tablet once daily. |
| Placebo B (NNC0487-0111 B) | OTHER | Participants will receive placebo matched to NNC0487-0111 B tablet once daily. |
| Placebo A (NNC0487-0111 A) | OTHER | Participants will receive placebo matched to NNC0487-0111 A tablet once daily. |
Inclusion Criteria: * Females of non-childbearing potential. * Age 18 - 65 years (both inclusive) at the time of signing the informed consent. * Body mass index (BMI) between 25.0 and 39.9 kg/m\^2 (both inclusive) at screening. * Considered to be generally healthy based on the medical history, phys...